The AI device record, tracked
FDA keeps an official list of Artificial Intelligence-Enabled Medical Devices. It is a downloadable file, updated a few times a year, with no alerts, no cross-links and no analytics. Atlas ingests it weekly and joins it to the clearance record: 1,524 authorized AI devices, each linked to its 510(k) page, recalls and review-time context.
Authorizations by year
2025 set the single-year record with 333 authorizations. The current year reflects FDA's publication lag: devices typically appear on the list two to three months after their decision date.
By lead panel
By pathway
510(k): 1,466
De Novo: 39
PMA: 19
Nearly all AI devices reach market through the 510(k) pathway, which makes predicate research the core of AI regulatory strategy.
Hear about the next one
FDA announces nothing when the list grows. Watch it here and every newly listed AI device lands in your change alerts the week Atlas picks it up.
Latest listed AI devices
| Decision | Device | Company | Panel | Pathway |
|---|---|---|---|---|
| 2026-03-30 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | Radiology | 510(k) |
| 2026-03-28 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | Cardiovascular | 510(k) |
| 2026-03-27 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | Radiology | 510(k) |
| 2026-03-27 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | Radiology | 510(k) |
| 2026-03-27 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | 510(k) |
| 2026-03-27 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | 510(k) |
| 2026-03-27 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Radiology | 510(k) |
| 2026-03-27 | S-scan Open (100001800) | Esaote, S.p.A. | Radiology | 510(k) |
| 2026-03-27 | Contour ProtégéAI+ | Mim Software, Inc. | Radiology | 510(k) |
| 2026-03-26 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Neurology | 510(k) |
| 2026-03-26 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | Radiology | 510(k) |
| 2026-03-26 | SwiftMR | Airs Medical, Inc. | Radiology | 510(k) |
| 2026-03-24 | Trinias | Shimadzu Corporation | Radiology | 510(k) |
| 2026-03-24 | JLK-NCCT | JLK, Inc. | Radiology | 510(k) |
| 2026-03-24 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | 510(k) |
| 2026-03-23 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | 510(k) |
| 2026-03-23 | True Definition DL | Ge Healthcare Japan Corporation | Radiology | 510(k) |
| 2026-03-20 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | Radiology | 510(k) |
| 2026-03-20 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Radiology | 510(k) |
| 2026-03-19 | AutoContour (RADAC V5) | Radformation, Inc. | Radiology | 510(k) |
| 2026-03-18 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | Radiology | 510(k) |
| 2026-03-17 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | Ear Nose & Throat | De Novo |
| 2026-03-17 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | Radiology | 510(k) |
| 2026-03-16 | SurgiCount+ System | Stryker Instruments | General Hospital | 510(k) |
| 2026-03-16 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | Radiology | 510(k) |
| 2026-03-16 | Sonio Detect (v3) | Sonio | Radiology | 510(k) |
| 2026-03-13 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | 510(k) |
| 2026-03-13 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | Radiology | 510(k) |
| 2026-03-12 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Cardiovascular | 510(k) |
| 2026-03-12 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | Gastroenterology-Urology | 510(k) |
Devices link to their Atlas clearance page where one exists, otherwise to the FDA database record. The full list is queryable through the API and the MCP server.
Methodology
Source: FDA's Artificial Intelligence-Enabled Medical Devices list, fetched weekly and joined to openFDA clearance records by submission number. openFDA itself exposes no AI field on any endpoint; this page exists because the join does not exist anywhere else. FDA updates the list periodically and notes device inclusion reflects the marketing submission, not a certification of AI performance. Verify decisions of consequence against the primary source.
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